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Saturday 01 December 2001

Effect of topotecan infusion duration on hematologic toxicity in recurrent ovarian carcinoma.

By: Puls LE, Hunter JE, Crane MM.

Med Oncol 2002;19(1):25-33

In an open-label, multicenter, nonrandomized, counterbalanced study, we investigated the tolerability and antitumor profile of a 10-min infusion duration of topotecan. A total of 12 patients with evaluable recurrent ovarian cancer were enrolled into the study and treated with 1.5 mg/m2/d topotecan for 5 d of a 21-d course by either a 10-, 30-, or 120-min intravenous infusion. Patients were evaluated for tolerability and tumor response. The primary toxicity associated with topotecan was noncumulative myelosuppression. All 12 patients experienced grade 3/4 neutropenia. Grade 3/4 thrombocytopenia, leukopenia, and anemia were reported in five (42%), two (17%), and two (17%) patients, respectively. Likewise, the majority of courses were associated with hematologic toxicity, with grade 3/4 neutropenia, thrombocytopenia, leukopenia, and anemia reported in 97%, 19%, 6%, and 6% of courses, respectively. The infusion duration had little impact on the myelotoxicity profile of topotecan. The mean nadir levels for all hematologic parameters were similar for all infusion durations, and myelosuppression was reversible and returned to near-preinfusion levels prior to administering the subsequent course, irrespective of infusion duration. A complete response was obtained by three (25%) patients, and five (42%) patients achieved stable disease; therefore, 67% of patients obtained clinical benefit. The results of this study demonstrate that topotecan administered over a 10-min interval has a comparable tolerability and safety profile compared with a 30-min infusion. A 10-min infusion may result in greater patient convenience and a reduction in the consumption of healthcare resources.

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